Blood sampling system and method

ABSTRACT

This disclosure relates to a system and method for drawing blood from a user by skin puncture instead of venous puncture and storing it for analysis. The system includes a receptacle configured to engage an area of skin of the user at a blood draw location and store blood drawn from the user; a lancet device disposed within the receptacle configured to puncture the skin of the user at the blood draw location; a vacuum device configured to reduce a pressure within the receptacle such that the skin at the blood draw location is drawn into the receptacle before the lancet device punctures the skin, and to enhance blood flow while blood is drawn from the user; and a housing configured to house the receptacle, the lancet device, and the vacuum device. The receptacle, the lancet device, and the vacuum device may be modular and removably coupled with the housing.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation filing of, and claims the benefit ofU.S. patent application Ser. No. 15/661,396, filed Jul. 27, 2017, whichclaims priority to U.S. Provisional Application No. 62/368,011, filed onJul. 28, 2016, entitled “BLOOD SAMPLING SYSTEM AND METHOD”. The entirecontents of the foregoing applications are incorporated herein byreference, including all text, tables and drawings.

FIELD OF THE DISCLOSURE

This disclosure relates to a blood sampling system and method fordrawing and storing blood from a user for analysis.

BACKGROUND

Obtaining enough high quality DNA and/or other analytes from bloodwithout having to perform venous puncture may be difficult. Whileobtaining saliva or buccal samples may be alternatives to blood samplesfor some genetic tests, there may be a high failure rate in tests usingsuch non-blood samples where failure may result from conditions specificto a patient and/or operating errors. Additionally, other analytespresent in the blood (e.g., cell free DNA, biochemistry markers, and/orother biomarkers) may be desired for genetic testing which would not beobtainable through saliva and/or buccal samples. Moreover, conventionalcutaneous blood collection methods such utilizing lancets to obtainblood from a finger-tip (e.g., blood glucose monitoring) may draw aninadequate quantity of blood required for genetic tests.

SUMMARY

The present disclosure provides systems and methods to obtain adequatequantities of blood (e.g. at least 0.5 mL) for testing, includinggenetic testing, without performing venous puncture, wherein the systemsand methods may be utilized at home and/or outside of a clinic by auser.

One aspect of the disclosure relates to a blood sampling systemconfigured to draw and store blood from a user for analysis. The systemcomprises a receptacle configured to engage an area of skin of the userat a blood draw location and store blood drawn from the user. The systemfurther comprises a lancet device disposed within the receptacleconfigured to puncture the skin of the user at the blood draw location.The system further comprises a vacuum device configured to reduce apressure within the receptacle. The vacuum device is configured suchthat the skin in response to the reduced pressure in the receptacle atthe blood draw location is drawn inward into the receptacle before thelancet device punctures the skin. The reduced pressure provided by thevacuum device may further enhance blood flow while blood is drawn fromthe user. The system further comprises a housing configured to house,partially house, or connect the receptacle, the lancet device, and thevacuum device. The receptacle, the lancet device, and the vacuum devicemay be modular and removably coupled with the housing.

Another aspect of the disclosure relates to a method for drawing andstoring blood from a user for analysis with a blood draw and storagesystem. The system comprises a receptacle, a lancet device, a vacuumdevice, a housing, and/or other components. The receptacle, the lancetdevice, the vacuum device, and/or other components are housed within,partially housed within, or connected by the housing. The receptacle,the lancet device, and the vacuum device may be modular and removablycoupled with the housing. The method comprises engaging, with thereceptacle, an area of skin of the user at a blood draw location. Themethod further comprises puncturing, with the lancet device, the skin ofthe user at the blood draw location. The method further comprisesreducing, with the vacuum device, a pressure within the receptacle. Thepressure within the receptacle is reduced such that the skin at theblood draw location is drawn inward into the receptacle before thelancet device punctures the skin. Furthermore, the reduced pressurewithin the receptacle may also enhance blood flow while blood is drawnfrom the user. The method further comprises storing, within thereceptacle, blood drawn from the user.

These and other features, and characteristics of the present technology,as well as the methods of operation and functions of the relatedelements of structure and the combination of parts and economies ofmanufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a schematic of a system configured to draw and storeblood from a user for analysis.

FIG. 2 illustrates modular components of the system according to one ormore embodiments.

FIG. 3 illustrates a position of the receptacle and the lancet devicewith respect to the housing according to one or more embodiments.

FIG. 4 illustrates a protective film covering comfort pad according toone or more embodiments.

FIG. 5 illustrates a capped modular component including the receptacle,the substrate, the lancet device, and a cap according to one or moreembodiments.

FIG. 6 illustrates a method for drawing and storing blood from a userfor analysis.

FIGS. 7a-7d illustrate a method of for drawing and storing blood from auser for analysis with a system having a vacuum chamber for reducing apressure within the receptacle according to one or more embodiments.

DETAILED DESCRIPTION

As used herein, the statement that two or more parts or components are“coupled” shall mean that the parts are joined or operate togethereither directly or indirectly, i.e., through one or more intermediateparts or components, so long as a link occurs. As used herein, “directlycoupled” means that two elements are directly in contact with eachother. As used herein, “fixedly coupled” or “fixed” means that twocomponents are coupled so as to move as one while maintaining a constantorientation relative to each other.

As used herein, the word “unitary” means a component is created as asingle piece or unit. That is, a component that includes pieces that arecreated separately and then coupled together as a unit is not a“unitary” component or body. As employed herein, the statement that twoor more parts or components “engage” one another shall mean that theparts exert a force against one another either directly or through oneor more intermediate parts or components. As employed herein, the term“number” shall mean one or an integer greater than one (i.e., aplurality).

Directional phrases used herein, such as, for example and withoutlimitation, top, bottom, left, right, upper, lower, front, back, andderivatives thereof, relate to the orientation of the elements shown inthe drawings and are not limiting upon the claims unless expresslyrecited therein.

Current solutions to obtain blood samples from a user without using avenous draw include utilizing a lancet to make an incision on the user'sskin, and using a capillary tube and/or test strip to draw blood fromthe incision. Use of lances on a finger may be very painful andinconvenient. Other alternative lancing solutions include utilizing alaser lance. Moreover, present solutions may require immediate use of ablood sample to analyze, via blood chemistry analysis materials presenton test strips, a particular biomarker. As such, present solutions maynot facilitate storage and/or shipment of a blood sample to a laboratoryfor testing, particularly when quantities required for testing exceed0.5 mL of blood. Accordingly, it is an object of this disclosure toprovide a system and method for remote collection of blood, wherein ablood sample is immediately stabilized for shipment and/or storage.

FIG. 1 illustrates a schematic of a system 10 configured to draw andstore blood from a user for analysis. In one embodiment, system 10comprises one or more of a receptacle 12, a substrate 14, an analogindicator 16, a lancet device 18, a vacuum device 20, an electronicsensor 22, a pressure sensor 24, a controller 26, an LED indicator 28,an electronic storage unit 36, and/or other components. In someembodiments, receptacle 12, substrate 14, analog indicator 16, lancetdevice 18, vacuum device 20, electronic sensor 22, pressure sensor 24,controller 26, LED indicator 28, electronic storage unit 36, and/orother components may be housed by housing 30. In some embodiments,receptacle 12, substrate 14, analog indicator 16, lancet device 18,vacuum device 20, electronic sensor 22, pressure sensor 24, controller26, LED indicator 28, and/or electronic storage unit 36 may be modularcomponents and being housed by housing 30 is and/or includes thesecomponents being removably coupled to housing 30.

Receptacle 12 is configured to engage an area of skin of the user at ablood draw location and store blood drawn from the user. In someembodiments, the blood draw location may comprise a thenar, a forearm, ashoulder, and/or other areas on the user's body. In some embodiments,receptacle 12 has a volume of at least 1 mL. In some embodiments,receptacle 12 may have a volume of at least 0.5 mL. In some embodiments,receptacle may have a volume of at least 2 mL. In some embodiments,receptacle 12 comprises one or more of glass, plastic, and/or othermaterials. In some embodiments, receptacle 12 comprises an opening at afirst end (e.g. opening at first end 220 as illustrated in FIG. 2) suchthat skin of the user is drawn into the receptacle prior to and/or whileblood is drawn from the user. In some embodiments, receptacle 12comprises a second end (e.g. second end 260 as illustrated in FIG. 2),opposite the first end, wherein the second end is hermetically sealed orotherwise sealed sufficient to support reduced pressure in receptacle12. In some embodiments, receptacle 12 forms a seal through positioningagainst a component of housing 30. In some embodiments, receptacle 12 issubstantially transparent to facilitate the user to view bloodcollected. In some embodiments, receptacle 12 may have a cylindricalshape and/or any other shape facilitating modular coupling with housing30. By way of a non-limiting example, FIGS. 2 and 3 illustrate aposition of receptacle 12 with respect to housing 30 according to one ormore embodiments. As shown in FIGS. 2 and 3, receptacle 12 is disposedwithin opening 240, between first end 330 and recessed portion 250.Moreover, as shown in FIG. 3, receptacle 12 may be positioned alongfirst axis 310.

In some embodiments, receptacle 12 includes blood storage substrate 14configured to absorb blood from the punctured skin. In some embodiments,substrate 14 does not cover the punctured skin of the user such thatblood flow is maintained. In some embodiments, substrate 14 is toroidalshaped and positioned around lancet device 18 such that lancet device 18punctures the skin of the user within an opening in the middle of thetoroidal shape. In some embodiments, substrate 14 may include acollection media including one or more of Whatman sample collectioncard, FTA card, Guthrie card material, and/or other solid, liquid, orgel stabilization matrix. In some embodiments, substrate 14 isconfigured to stabilize nucleic acids, proteins, chemicals, and/or otherblood components. In some embodiments, substrate 14 may include filterpaper. In some embodiments, a diameter of the opening in a toroidalshaped substrate 14 is between about 2 mm and about 10 mm. In someembodiments, the diameter is about 3 mm and/or any other diameter. Insome embodiments, receptacle 12 and/or blood storage substrate 14 areconfigured such that the opening in the toroidal shape is approximatelycentered around the wound at the blood draw location. By way of anon-limiting example, FIG. 2 illustrates modular components of system 10according to one or more embodiments. As shown in FIG. 2, substrate 14is disposed at or near first end 220 of receptacle 12.

Returning to FIG. 1, lancet device 18 is disposed within receptacle 12.Lancet device 18 is configured to puncture the skin of the user at theblood draw location. Lancet device 18 may be advanced to puncture theskin by any mechanical means. In some embodiments, lancet device 18 maybe propelled by a spring or elastic material. In some embodiments,lancet device 18 may be propelled by a piston or motor. In someembodiments, lancet device 18 may be actuated manually by the user. Insome embodiments, lancet device 18 may be automatically launched whensufficient pressure reduction is achieved in receptacle 12. Retractionof lancet device 18 may be achieved by any mechanical means, includingthe spring or elastic which propelled lancet device 18 forward, or amotor, piston, or other mechanism for withdrawing lancet device 18. Insome embodiments, lancet device 18 may be configured such that aquantity of blood drawn from the wound created by lancet device 18 is atleast 0.5 mL of blood. In some embodiments, at least 600 μL, 700 μL, 800μL, 900 μL, 1 mL, 1.125 mL, 1.5 mL, 1.75 mL, 2.0 mL, 2.5 mL, 3 mL, orany other quantity of blood may be drawn. In some embodiments, at least17 or 18 gauge (or any gauge supporting sufficient quantity of bloodcollection while minimizing user pain and time for wound closure)lancets may be provided to facilitate drawing at least 0.5 mL of blood.In some embodiments, lancet device 18 comprises multiple lancetsconfigured to puncture the skin at the blood draw location. Multiplepunctures in proximity to one another may increase blood flow. In someembodiments, the multiple punctures may be within receptacle 12 at theblood draw location. In some embodiments, the multiple punctures may belocated with the opening in the middle of the toroidal shape. Paininvolved in puncturing may increase marginally responsive to multiplelancets being fired simultaneously (e.g., compared to pain caused by asingle lancet). Use of an 18 gauge lance on a finger may be painfuland/or inconvenient, while puncturing the thenar area may be lesspainful. However, due to different hand sizes, wrinkles, and/or strongcurvature of the tissue in the thenar area, drawing blood from thethenar may also be challenging. As such, receptacle 12, lancet device18, and/or other components of system 10 may be configured to engage thethenar area of a user and/or other areas. In some embodiments,puncturing may be performed on a forearm of a user, since there may befewer, but enough, blood vessels in the forearm and the puncturing maycause very little pain. In some embodiments, puncturing may be performedon a shoulder of the user as puncturing skin on a shoulder tissue maycause minimal pain. In some embodiments, at least a portion of lancetdevice 18 is coated with an anticoagulant coating such that healing ofthe wound caused by the lancing is delayed due to a temporary disruptionof blood clotting caused by the anticoagulant coating. As such the woundis maintained open while blood is drawn from the user. By way of anon-limiting example, FIG. 2 illustrates lancet device 18 disposedwithin receptacle 12. As shown in FIG. 2, substrate 14 is toroidalshaped and positioned around lancet device 18. Furthermore, as shown inFIGS. 2 and 3, lancet device 18 may be disposed toward first end 330.Moreover, as depicted in FIG. 3, lancet device 18 may be located alongfirst axis 310.

Returning to FIG. 1, in some embodiments, system 10 applies a vacuum toa blood draw location such that skin at the blood draw location isstretched, and the wound, caused by the lancing process, is kept open,and blood is drawn out of the user's body. Vacuum device 20 isconfigured to reduce a pressure within receptacle 12 (a) such that theskin at the blood draw location is drawn into receptacle 12 before thelancet device 18 punctures the skin, and (b) to enhance blood flow whileblood is drawn from the user. The reduced pressure may cause the skin toform a slight dome shape inward into receptacle 12 or may cause the skinto be substantially drawn into receptacle 12. In some embodiments,vacuum device 20 comprises a motorized vacuum pump. In some embodiments,vacuum device 20 comprises a piston which may be drawn by a motor ormanually to reduce pressure in receptacle 12. In some embodiments,vacuum device 20 is in fluid communication with receptacle 12. In someembodiments, the pump draws air from within receptacle 12 through anopening and/or conduit in fluid communication with receptacle 12 toreduce the pressure within receptacle 12. In some embodiments, vacuumdevice 20 comprises a vacuum chamber configured to reduce the pressurewithin receptacle 12 responsive to the vacuum chamber being pierced. Insome embodiments, lancet device 18 is within receptacle 12, or inothers, may travel through receptacle 12 to the skin. The reducedpressure within receptacle 12 may be ended at the completion of theblood draw by piercing or breaking the vacuum. Such piercing of thevacuum may be accomplished by mechanical means to allow air to enterreceptacle 12 and raise the pressure to approximately the ambient airpressure. Such piercing may be effectuated automatically by system 10 inresponse to detection of adequate blood drawn or manually by the user.In some embodiments, vacuum device 20 is configured to create a pressurereduction of between 1-500 mbars, or 50-500 mbars, or 100-500 mbars, orat least 100, 150, 200, 250, 300, 350, 400, or 500 mbars withinreceptacle 12. As shown in FIGS. 2 and 3, vacuum device 20 may belocated between first opening 240 and second end 340. Furthermore, asillustrated in FIG. 3, vacuum device 20 may be disposed along secondaxis 320.

Analog indicator 16 is configured to indicate of a quantity of blood inreceptacle 12. In some embodiments, analog indicator 16 is configured tobe visible to the user through a viewing window of receptacle 12. Insome embodiments, analog indicator 16 is coupled with receptacle 12and/or other components of system 10 in a location that facilitates adetermination of the amount of blood in receptacle 12 and/or viewing ofthe indication provided by analog indicator 16. In some embodiments,analog indicator 16 may be and/or include a series of colored markers, agraduated cylinder, a thermometer type scale, a dial, needle, capillarytubes, filter material, narrow wick, and/or other indicators disposedwithin and/or in communication with receptacle 12.

Pressure sensor 24 is configured to generate output signals that conveyinformation related to a pressure within receptacle 12. Pressure sensor24 may be disposed within receptacle 12 such that operation of lancetdevice 18 is not impeded and/or obstructed. Furthermore, pressure sensor24 may be disposed such that a blood sample stored within receptacle 12is not contaminated and/or otherwise disturbed by pressure sensor 24. Insome embodiments, pressure sensor 24 is disposed in a space betweensubstrate 14 and the second end of receptacle 12. In some embodiments,pressure sensor 24 is coupled with other components of system 10 (e.g.,controller 26) via wires and/or wirelessly.

Electronic sensor 22 is configured to generate output signals thatconvey information related to a quantity of blood in receptacle 12. Insome embodiments, electronic sensor 12 may measure a conductivity ofsubstrate 14 at multiple locations to determine the quantity of blood inreceptacle 12. In some embodiments, electronic sensor 22 is coupled withother components of system 10 via wires and/or wirelessly.

Controller 26 is configured to provide information processingcapabilities in system 10. As such, controller 26 may comprise one ormore of a digital processor, an analog processor, a digital circuitdesigned to process information, an analog circuit designed to processinformation, a state machine, and/or other mechanisms for electronicallyprocessing information. Although controller 26 is shown in FIG. 1 as asingle entity, this is for illustrative purposes only. In someembodiments, controller 26 may comprise a plurality of processing units.These processing units may be physically located within the same device(e.g., within housing 30), or controller 26 may represent processingfunctionality of a plurality of devices operating in coordination (e.g.,system 10 may be wirelessly controlled by a remotely located processor.)In some embodiments, controller 26 is operatively connected to lancetdevice 18, vacuum device 20, LED indicator 28, pressure sensor 24,and/or electronic sensor 22. Controller 26 may be communicativelycoupled with an electronic storage unit 36.

In some embodiments, controller 26 is configured to, responsive tosignals received from pressure sensor 24 indicating the pressure in thereceptacle breaching a predetermined pressure threshold level, causelancet device 18 to puncture the skin of the user. In some embodiments,the pressure threshold level may be about 50, 100, 150, 200, 250, 300,350, 400, 450, 500 mbars, or more pressure reduction relative to ambientpressure. In some embodiments, controller 26 is configured to,responsive to signals received from electronic sensor 22, determine aquantity of blood in receptacle 12. In some embodiments, controller 26is configured to, responsive to the signals received from electronicsensor 22 indicating that a quantity of blood in receptacle 12 hasbreached a predetermined amount of blood, cause vacuum device 20 tocease the application of the vacuum pressure. In some embodiments, thepredetermined amount of blood may be at least 500 μL, 600 μL, 700 μL,800 μL, 900 μL, 1 mL, 1.2 mL, 1.4 mL, 1.6 mL, 1.8 mL, 2.0 mL, 2.5 mL, 3mL, and/or other quantities of blood . In some embodiments, controller26 is configured to cause vacuum device 20 to maintain the vacuumpressure for a predetermined amount of time, regardless of the amount ofblood in receptacle 12. The predetermined amount of time may beprogrammed at manufacture, determined and/or adjusted by controller 26,and/or determined in other ways. The predetermined amount of time may bechosen based upon the amount of time required to draw an adequate amountof blood. In some embodiments, system 10 may draw blood into receptacle12 until receptacle 12 is substantially full.

Electronic storage unit 36 comprises electronic storage media thatelectronically stores information. The electronic storage media ofelectronic storage unit 36 may comprise one or both of system storagethat is provided integrally (i.e., substantially non-removable) withsystem 10 and/or removable storage that is removably connectable tosystem 10 via, for example, a port (e.g., a USB port, a firewire port,etc.) or a drive (e.g., a disk drive, etc.). Electronic storage unit 36may be (in whole or in part) a separate component within system 10, orelectronic storage unit 36 may be provided (in whole or in part)integrally with one or more other components of system 10 (e.g.,controller 26, etc.). Electronic storage unit 36 may comprise one ormore of optically readable storage media (e.g., optical disks, etc.),magnetically readable storage media (e.g., magnetic tape, magnetic harddrive, floppy drive, etc.), electrical charge-based storage media (e.g.,EPROM, RAM, etc.), solid-state storage media (e.g., flash drive, etc.),and/or other electronically readable storage media. Electronic storageunit 36 may store software algorithms, information determined bycontroller 26, information received from electronic sensor 22,information received from pressure sensor 24, and/or other informationthat enables system 10 to function as described herein. By way of anon-limiting example, electronic storage unit 36 may store thepredetermined pressure threshold level, blood amount, and/or otherinformation.

In some embodiments, controller 26 is communicatively and/or operativelycoupled with an LED indicator device 28. LED indicator device 28 isconfigured to indicate the quantity of blood in the receptacle or thatan amount greater than a predetermined volume of blood is in receptacle12. In some embodiments, responsive to controller 26 determining thequantity of blood in receptacle 12, LED indicator device 28 is caused todisplay a progress of blood collection. In some embodiments, controller26 controls LED indicator device 28 to indicate amount of blood bycausing LED indicator device 28 to partially/fully light up as theamount of blood received in receptacle 12 increases (such that thelighting of one or more LEDs included in LED device 28 corresponds toblood in receptacle 12). In some embodiments, LED indicator device 28 isconfigured to provide an indication responsive to a wound being clogged.By way of a non-limiting example, FIG. 2 illustrates LED indicatordevice 28 coupled with a second surface 230 of a housing 30. In someembodiments, LED indicator device 28 may be facing away from the skinduring blood collection to facilitate a visible indication of an amountof blood collected. Furthermore, as illustrated in FIGS. 2 and 3, LEDindicator device 28 may be located toward second end 340. Moreover, asshown in FIG. 3, LED indicator device 28 may be disposed on secondsurface 230, substantially parallel to second axis 320.

Returning to FIG. 1, housing 30 is configured to house, partially house,or connect receptacle 12, lancet device 18, the vacuum device 20,electronic sensor 22, pressure sensor 24, LED indicator unit 28,electronic storage unit 36, and/or other components of system 10. Insome embodiments, receptacle 12, lancet device 18, vacuum device 20,electronic sensor 22, pressure sensor 24, LED indicator unit 28,electronic storage unit 36, and/or other components of system 10 aremodular and/or removably coupled with housing 30. As shown in FIG. 2,receptacle 12, lancet device 18, vacuum device 20 are removably coupledwith housing 30. In this example, housing 30 is shown to have a recessedportion 250 configured such that vacuum device 20 and/or othercomponents are arranged and secured within recessed portion 250. Housing30 may have any structure or geometry allowing for components to connectwith one another and/or housing 30. In some embodiments, housing 30 maybe comprised of any rigid or semi rigid material such as plastic orpolymeric materials. In some embodiments, housing 30 may have an opening240 configured such that receptacle 12, lancet device 18, and/or othercomponents are arranged and secured within opening 240. By way of anon-limiting example, FIG. 3 illustrates a position of receptacle 12 andlancet device 18 with respect to housing 30 according to one or moreembodiments. As shown in FIG. 3, housing 30 comprises a first axis 310extending in a first direction and a second axis 320 extending in asecond direction. In some embodiments, lancet device 18 and receptacle12 are positioned along the first axis of housing 30. In someembodiments, housing 30 comprises a first end 330 adjacent to firstopening 240, a second end 340, opposite first end 330, and a first side350 between first end 330 and second end 340. In some embodiments,lancet device 18 and receptacle 12 are positioned at and/or near firstend 330. Returning to FIG. 2, housing 30 comprises a first surface 210,opposite second surface 230. First surface 210 is configured to face theskin of the user while blood is drawn from the user. In someembodiments, first surface 210 is coupled to a comfort pad 32.

Comfort pad 32 is configured to face the skin of the user while blood isdrawn from the user. Comfort pad 32 may provide more comfort for theuser while blood is drawn from the user and may ensure a better vacuumwithin receptacle 12. In some embodiments, comfort pad 32 may be and/orinclude an adhesive foam pad configured to minimize air leakage betweensystem 10 and the skin and prevent system 10 from moving relative to theuser's skin while blood is being drawn from the user. As shown in FIG.4, comfort pad 32 comprises an opening 420 to facilitate receptacle 12engaging the skin of the user at a blood draw location. FIG. 4illustrates a protective film 410 covering comfort pad 32 according toone or more embodiments. In some embodiments, the user removesprotective film 410 prior to placing system 10 on one of a forearm, ashoulder, or a thenar of the user.

Returning to FIG. 2, system 10 comprises a button and/or other interfacedevice 34 configured to activate system 10. Responsive to the userplacing system 10 against the skin at or near a blood draw location andthen pressing (for example) button 34, vacuum device 20 (shown inFIG. 1) reduces the pressure within receptacle 12 and lancet device 18punctures the skin of the user. Button 30 may initiate a signal whichcauses vacuum device 20 to begin reducing pressure in receptacle 12. Insome embodiments, button 34 may initiate a mechanical action whichcauses vacuum device 20 to reduce pressure in receptacle 12.

As shown in FIG. 2, receptacle 12 and lancet device 18 may be modularand removable from housing 30. In some embodiments, a blood samplecollected may be shipped to a laboratory facility and/or stored. By wayof a non-limiting example, FIG. 5 illustrates a capped modular component500 comprising receptacle 12, substrate 14, lancet device 18, and cap510 according to one or more embodiments. In this example, cap 510 isremovably coupled with first end 220 (e.g., the end that contacts theskin of the user) of receptacle 12 to prevent blood from escaping fromreceptacle 12 when blood is stored in receptacle 12. Cap 510 may attachto receptacle 12 in a snap-on, screw-on fashion or an elastic fit bystretching over opening 220.

FIG. 6 illustrates a method 600 for drawing and storing blood from auser for analysis with a blood drawing and storage system. The systemcomprises a receptacle, a lancet device, a vacuum device, a housing,and/or other components. The system may comprise any apparatus accordingto the invention. The operations of method 600 presented below areintended to be illustrative. In some embodiments, method 600 may beaccomplished with one or more additional operations not described,and/or without one or more of the operations discussed. Additionally,the order in which the operations of method 600 are illustrated in FIG.6 and described below is not intended to be limiting.

At an operation 602, an area of skin of the user at a blood drawlocation is engaged with the receptacle. In some embodiments, thereceptacle is housed within, partially housed within, or connected withthe housing. In some embodiments, the receptacle may be modular andremovably coupled with the housing. In some embodiments, the receptaclehas a volume of at least 1 mL. In some embodiments, the receptacle mayhave a volume of at least 0.5 mL, 2 mL, and/or other volumes. In someembodiments, a comfort pad is coupled with a first surface of thehousing. In some embodiments, the first surface of the housing is facingthe skin of the user while blood is drawn from the user. In someembodiments, the comfort pad is furnished to provide more comfort forthe user while blood is drawn from the user and ensure a better vacuumwithin the receptacle. In some embodiments, the comfort pad may includean adhesive foam pad configured to minimize air leakage between thedevice and the skin and prevent device movement while blood is beingdrawn from the user. In some embodiments, operation 602 is performed bya receptacle the same as or similar to receptacle 12 (shown in FIG. 1and described herein).

At an operation 604, a pressure within the receptacle is reduced with avacuum device. In some embodiments reducing the pressure within thereceptacle includes drawing the skin at the blood draw location inwardinto the receptacle before the lancet device punctures the skin. In someembodiments, the reduced pressure within the receptacle may enhanceblood flow while blood is drawn from the user. In some embodiments,reduced pressure within the receptacle is maintained while blood isdrawn from the user. In some embodiments, the vacuum device includes amotorized vacuum pump. In some embodiments, vacuum device comprises apiston which may be drawn by a motor or manually to reduce pressure inreceptacle. In some embodiments, the vacuum device includes a vacuumchamber configured to reduce the pressure within the receptacleresponsive to the vacuum chamber being pierced. The reduced pressurewithin the receptacle may be ended at the completion of the blood drawby piercing or breaking the vacuum. Such piercing of the vacuum may beaccomplished by mechanical means to allow air to enter the receptacleand raise the pressure to approximately the ambient air pressure. Suchpiercing may be effectuated automatically by the system in response todetection of adequate blood drawn or manually by the user. In someembodiments, output signals conveying information related to thepressure within the receptacle are generated with a pressure sensor. Insome embodiments, the vacuum device is housed within, partially housedwithin, or connected to the housing. In some embodiments, the vacuumdevice may be modular and removably coupled with the housing. In someembodiments, operation 604 is performed by a vacuum device the same asor similar to vacuum device 20 (shown in FIG. 1 and described herein).

At an operation 606, the skin of the user at the blood draw location ispunctured with a lancet device. In some embodiments, the lancet deviceis caused, with a controller, to puncture the skin of the userresponsive to the pressure in the receptacle breaching a thresholdlevel. The lancet device may be advanced to puncture the skin by anymechanical means. In some embodiments, the lancet device may bepropelled by a spring or elastic material. In some embodiments, thelancet device may be propelled by a piston or motor. In someembodiments, the lancet device may be actuated manually by the user. Insome embodiments, the lancet device may be automatically launched whensufficient pressure reduction is achieved in the receptacle. Retractionof the lancet device may be achieved by any mechanical means, includingthe spring or elastic which propelled the lancet device forward, or amotor, piston, or other mechanism for withdrawing the lancet device. Insome embodiments, the lancet device comprises multiple lancetsconfigured to puncture the skin at the blood draw location. In someembodiments, at least a portion of the lancet device is coated with ananticoagulant coating. In some embodiments, the lancet device is housedwithin, partially housed within, or connected to the housing. In someembodiments, the lancet device may be modular and removably coupled withthe housing. In some embodiments, operation 606 is performed by a lancetdevice the same as or similar to lancet device 18 (shown in FIG. 1 anddescribed herein).

In some embodiments, portion of operations 604 and 606 may be performedconcurrently or in an order different from what is described above suchthat the pressure is reduced within the receptacle prior to the lancetdevice puncturing the skin of the user and the reduced pressure withinthe receptacle is maintained while blood is drawn from the user.

At an operation 608, blood drawn from the user is stored with thereceptacle. In some embodiments, at least 0.5 mL of blood is drawn fromthe user and stored with the receptacle. In some embodiments, at least600 μL, 700 μL, 800 μL, 900 μL, 1 mL, 1.125 mL, 1.5 mL, 1.75 mL, 2.0 mL,2.5 mL, 3 mL, or any other quantity of blood may be drawn. In someembodiments, storing blood drawn from the user includes absorbing, witha blood storage substrate, blood from the punctured skin. In someembodiments, the blood storage substrate is disposed within thereceptacle. In some embodiments, the substrate is toroidal shaped andpositioned around the lancet device such that the lancet devicepunctures the skin of the user within an opening in the middle of thetoroidal shape. In some embodiments, the substrate does not cover thepunctured skin of the user. In some embodiments, storing blood drawnfrom the user includes removably coupling a cap with the receptacle toprevent blood from escaping from the receptacle when blood is stored inthe receptacle. In some embodiments, the cap may attach to thereceptacle in a Snap-On, screw-on fashion or an elastic fit bystretching over the receptacle opening. In some embodiments, outputsignals conveying information related to a quantity of blood in thereceptacle are generated with an electronic sensor. In some embodiments,operation 608 is performed by the receptacle as or similar to receptacle12 (shown in FIG. 1 and described herein).

At an operation 610, the quantity of blood in the receptacle isindicated. In some embodiments, an analog indicator indicates thequantity of blood in the receptacle. In some embodiments, output signalsconveying information related to a quantity of blood in the receptacleare generated with an electronic sensor. In some embodiments, operation610 includes indicating, with an LED indicator, the quantity of blood inthe receptacle responsive to the output signals generated by theelectronic sensor. In some embodiments, the LED indicator may indicatethat an amount greater than a predetermined volume of blood is in thereceptacle. In some embodiments, operation 610 is performed by an LEDindicator as or similar to LED indicator 28 (shown in FIG. 1 anddescribed herein).

FIGS. 7a-7d illustrate a method of for drawing and storing blood from auser for analysis with a system having a vacuum chamber for reducing apressure within the receptacle. In FIGS. 7a-7d components identified byprimed reference numerals resemble similar components illustrated inFIGS. 1-4. As shown in FIG. 7a , the user removes protective film 410′covering opening 420′ and adhesive foam pad 32′. Subsequent to theremoval of the protective film, the user places the system on one of aforearm, a shoulder, or a thenar of the user. Next, as illustrated inFIG. 7b , responsive to the user pressing button 34′, the lancet islaunched causing the vacuum chamber to be pierced. Following the lancetlaunch and as illustrated by FIG. 7c , responsive to the vacuum chamberbeing pierced, a pressure within the receptacle is reduced causing theskin to be pulled into the chamber. Subsequently, the lancet devicepunctures the skin of the user at a blood draw location. In thisexample, a quantity of blood drawn in the receptacle is indicated by amanual indicator. FIG. 7d illustrates a removal procedure of the systemfrom the user's body. In FIG. 7d the system is shown to be tilted to aside such that air is allowed in the receptacle in order to remove thesystem from the user's body.

In the claims, any reference signs placed between parentheses shall notbe construed as limiting the claim. The word “comprising” or “including”does not exclude the presence of elements or steps other than thoselisted in a claim. In a device claim enumerating several means, severalof these means may be embodied by one and the same item of hardware. Theword “a” or “an” preceding an element does not exclude the presence of aplurality of such elements. In any device claim enumerating severalmeans, several of these means may be embodied by one and the same itemof hardware. The mere fact that certain elements are recited in mutuallydifferent dependent claims does not indicate that these elements cannotbe used in combination.

Although the present technology has been described in detail for thepurpose of illustration based on what is currently considered to be themost practical and preferred implementations, it is to be understoodthat such detail is solely for that purpose and that the technology isnot limited to the disclosed implementations, but, on the contrary, isintended to cover modifications and equivalent arrangements that arewithin the spirit and scope of the appended claims. For example, it isto be understood that the present technology contemplates that, to theextent possible, one or more features of any implementation can becombined with one or more features of any other implementation.

1. A blood sampling system configured to draw and store blood from auser for analysis, the system comprising: a receptacle configured toengage an area of skin of the user at a blood draw location and storeblood drawn from the user; a lancet device disposed within and movablewithin the receptacle and configured to puncture the skin of the user atthe blood draw location; the receptacle further including a bloodstorage substrate configured to absorb blood from the punctured skin; avacuum device configured to reduce a pressure within the receptacle (1)such that the skin at the blood draw location is drawn into thereceptacle before the lancet device punctures the skin, and (2) toenhance blood flow while blood is drawn from the user; and a housing,wherein the receptacle together with the lancet device and the vacuumdevice are each modular and removably coupled with the housing, thehousing having an opening for removably receiving the receptacle withthe lancet device therein, wherein a first end of the receptaclecomprises an opening that is configured to engage the area of the skinand a second end of the receptacle is configured to be sealed to supportreduced pressure in the receptacle, and wherein the vacuum device isseparately removable from the housing relative to the receptacle. 2.-5.(canceled)
 6. The system of claim 1, wherein the substrate is toroidalshaped and positioned around the lancet device such that the lancetdevice punctures the skin of the user within an opening in the middle ofthe toroidal shape.
 7. The system of claim 1, further comprising a capthat removably couples with the receptacle to prevent blood fromescaping from the receptacle when blood is stored in the receptacle. 8.(canceled)
 9. The system of claim 1, wherein the lancet device comprisesmultiple lancets configured to puncture the skin at the blood drawlocation.
 10. The system of claim 1, wherein at least a portion of thelancet device is coated with an anticoagulant coating. 11.-12.(canceled)
 13. The system of claim 1, further comprising an analogindicator and/or an electronic sensor configured to convey informationof a quantity of blood in the receptacle.
 14. The system of claim 1,further comprising a button configured to initiate action of the vacuumdevice to reduce pressure in the receptacle.
 15. The system of claim 13,further comprising an LED indicator device coupled with the housing, theLED indicator device configured to indicate the quantity of blood in thereceptacle.
 16. The system of claim 1, further comprising a pressuresensor configured to generate output signals that convey informationrelated to a pressure within the receptacle, the pressure sensor beingdisposed within the receptacle; and a controller configured to,responsive to the pressure in the receptacle breaching a thresholdlevel, cause the lancet device to puncture the skin of the user.
 17. Thesystem of claim 1, further comprising a comfort pad coupled with a firstsurface of the housing, the first surface of the housing facing the skinof the user while blood is drawn from the user.
 18. (canceled)
 19. Amethod for drawing and storing blood from a user for analysis with asystem comprising a receptacle, a lancet device, a vacuum device, and ahousing, the method comprising: engaging, with the receptacle, an areaof skin of the user at a blood draw location; puncturing, with thelancet device, the skin of the user at the blood draw location, thelancet device being disposed within and movable within the receptacle;absorbing, with a blood storage substrate, blood from the puncturedskin, wherein the blood storage substrate is disposed within thereceptacle; reducing, with the vacuum device, a pressure within thereceptacle (1) such that the skin at the blood draw location is drawninto the receptacle before the lancet device punctures the skin, and (2)to enhance blood flow while blood is drawn from the user; and storing,with the receptacle, blood drawn from the user, wherein the receptacletogether with the lancet device and the vacuum device are each modularand removably coupled with the housing, the housing having an openingfor removably receiving the receptacle with the lancet device therein,wherein a first end of the receptacle comprises an opening that isconfigured to engage the area of the skin and a second end of thereceptacle is configured to be sealed to support reduced pressure in thereceptacle, and wherein the vacuum device is separately removable fromthe housing relative to the receptacle. 20.-24. (canceled)
 25. Themethod of claim 19, further comprising indicating, with an LEDindicator, a quantity of blood in the receptacle responsive to outputsignals generated by an electronic sensor. 26.-27. (canceled)
 28. Themethod of claim 19, further comprising causing, by a controller, thelancet device to puncture the skin of the user responsive to thepressure in the receptacle breaching a threshold level. 29.-30.(canceled)
 31. A receptacle comprising: a first end and a second end,the second end being opposite the first end and being sealed to supportreduced pressure in the receptacle, the first end of the receptaclebeing configured to engage an area of skin of a user at a blood drawlocation and store blood drawn from the user; a lancet device disposedwithin and movable therein between the first end and the second endthereof and configured to puncture the skin of the user at the blooddraw location; a blood storage substrate in the receptacle and disposedat or near the first end thereof, the blood storage substrate beingconfigured to absorb blood from the punctured skin, the blood storagesubstrate comprising a solid, liquid, or gel stabilization matrix,wherein the receptacle and the lancet device are modular and the lancetdevice being removable together with the receptacle.
 32. The receptacleaccording to claim 31, wherein the receptacle has a cylindrical shape.33. The receptacle according to claim 31, wherein the blood storagesubstrate is toroidal shaped and positioned around lancet device suchthat lancet device is configured to puncture the skin of the user withinan opening in a middle of the toroidal shape.
 34. The receptacleaccording to claim 31, further comprising an analog indicator configuredto indicate of a quantity of blood in the receptacle.
 35. The receptacleaccording to claim 31, further comprising a cap that is removablycouplable with the first end of the receptacle to prevent blood fromescaping from the receptacle when blood is stored therein.
 36. Thereceptacle according to claim 31, wherein the receptacle has a volume ofat least 0.5 mL.
 37. The receptacle according to claim 31, wherein thelancet device includes a 17 gauge or an 18 gauge lancet.
 38. Thereceptacle according to claim 31, wherein the lancet device comprisesmultiple lancets configured to puncture the skin at the blood drawlocation.
 39. The receptacle according to claim 31, wherein at least aportion of the lancet device is coated with an anticoagulant coating.40. The receptacle according to claim 31, wherein the stabilizationmatrix stabilizes nucleic acids present in a blood sample.